AATec Medical Partners with Northway Biotech to Scale ATL-105 Production for Non-CF Bronchiectasis Treatment
核心洞察
AATec Medical (搜索) and Northway Biotech (搜索) have formed a partnership to develop and scale industrial production of ATL-105, a novel recombinant alpha-1 antitrypsin therapy for non-cystic fibrosis bronchiectasis (搜索).
ATL-105 represents a new generation of inhaled biologics that combines anti-protease, anti-inflammatory, and anti-infective properties in a single molecule delivered directly to the lungs.
The partnership will leverage Northway Biotech (搜索)'s expertise in biologics manufacturing using the Pichia pastoris expression system to establish a robust production process for clinical development and commercial use.
AATec Medical (搜索) GmbH and Northway Biotech (搜索) have announced a strategic partnership to develop and scale the industrial production process for ATL-105, a proprietary inhaled therapy based on recombinant alpha-1 antitrypsin (AAT) targeting non-cystic fibrosis bronchiectasis (搜索) (NCFB (搜索)). The collaboration aims to establish a robust manufacturing foundation as AATec prepares for clinical trials of its lead product candidate.
Novel Multimodal Approach to Respiratory Disease
ATL-105 represents what AATec describes as "a new generation of inhaled biologics," combining anti-protease, anti-inflammatory, and anti-infective properties within a single molecule. The therapy is designed for direct pulmonary delivery, enabling targeted action with minimal systemic exposure.
"ATL-105 represents a new generation of inhaled biologics, combining anti-protease, anti-inflammatory, and antiinfective properties in one molecule. Delivered directly to the lungs, it enables fast, targeted action with minimal systemic exposure," said Dr. Rüdiger Jankowsky, co-founder and CEO of AATec Medical (搜索). "We believe ATL-105 can redefine care in respiratory diseases with high medical need, such as non-CF bronchiectasis."
Manufacturing Partnership Details
Under the agreement, Northway Biotech (搜索) will leverage its expertise in biologics manufacturing to develop and scale the production process for ATL-105 using the Pichia pastoris expression system. The partnership encompasses both manufacturing process development and analytical development components.
"With this partnership, we are establishing a robust and scalable production process for ATL-105, laying the foundation for consistent quality for clinical development and commercial use," Jankowsky explained.
Prof. Vladas Algirdas Bumelis, CEO and Chairman of Northway Biotech (搜索), emphasized the company's commitment to supporting the program's advancement. "AATec is advancing a promising therapeutic solution addressing significant unmet medical needs, supported by a highly capable and dedicated team. With our decades of expertise in microbial systems, we are well-positioned to scale this program efficiently and deliver quality at every step."
Addressing Significant Unmet Medical Need
Non-CF bronchiectasis is a chronic inflammatory respiratory condition affecting millions of people worldwide. The debilitating disease is characterized by dilated bronchi, persistent inflammation, frequent airway infections, and impaired mucus clearance. AATec has successfully demonstrated proof-of-principle in several indications and is currently preparing for a proof-of-concept clinical trial with ATL-105 for inhaled application in NCFB (搜索).
Beyond its lead indication, ATL-105 demonstrates therapeutic potential for a broader range of inflammatory and infectious respiratory diseases, including COPD (搜索), ARDS (搜索), and other conditions, reflecting the versatility of its anti-inflammatory, immunomodulatory, and anti-infective properties.
Growing Market for Inhaled Protein Therapies
André Markmann, PhD, VP of Business Development at Northway Biotech (搜索), highlighted the expanding opportunity in inhaled protein therapeutics. "Inhaled protein therapies are gaining significant traction, and ATL-105 stands out as one of the most promising approaches in this area," he noted.
The partnership positions both companies to capitalize on the growing interest in direct pulmonary delivery of biologics, particularly for respiratory conditions where systemic therapies may present limitations or unwanted side effects.
Company Backgrounds
AATec Medical (搜索) GmbH is developing a multi-product platform based on novel recombinant versions of alpha-1 antitrypsin for treating respiratory inflammatory diseases, airway infections, and rare diseases. The company was founded by an interdisciplinary team with extensive experience in clinical research, biopharmaceutical development, and product industrialization.
Northway Biotech (搜索), founded in 2004, operates as a leading Contract Development and Manufacturing Organization specializing in protein-based biologics and gene therapies. The privately held company maintains state-of-the-art facilities in Lithuania and the United States, offering comprehensive biopharmaceutical development and manufacturing services from early-stage development through commercial production.